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Validation of Escala de Conductas Indicadoras de Dolor ESCID Scale for Measuring Pain in Critically Ill Patients

Estudio multicéntrico de Validez y Fiabilidad de la Escala de Conductas Indicadoras de Dolor ESCID Para Medir el Dolor en Pacientes críticos, no Comunicativos y Sometidos a ventilación mecánica

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01744717
Acronym
ESCID-MQ
Enrollment
286
Registered
2012-12-07
Start date
2012-11-30
Completion date
2016-06-30
Last updated
2016-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Pain, mechanical ventilation, uncommunicative, Adult ICU patients pain

Brief summary

Pain is an unpleasant and important stress factor, and a potentially harmful experience for critically ill patients. Pain is harder to evaluate in non-communicative patients, who can´t report their own pain. Behavioral indicators have been proved as useful and reliable for detecting and measuring pain in these patients, and have been the basis for constructing scales for measuring pain, such as the Behavioural Pain Scale (BPS), the Critical Care Observation Tool (CPOT) and the Scale of Behaviors Indicating Pain (ESCID) . The BPS and ESCID were tested in a study with a sample of 42 critically ill patients in Spain, showing good validity and reliability. The objective of this Spanish multicentre study is to test the validity and reliability of the ESCID scale in a large sample of critically ill patients with medical and postsurgical pathology for the detection and measurement of pain.

Detailed description

The specific Aims for the study are : To determine the validity and reliability of the ESCID scale to assess pain in non-communicative critically ill patients on mechanical ventilation, in a large sample of critically ill medical and surgical patients. To assess the relationship between the application of a common and painful procedure, usual in daily practice, and its associated changes in physiological indicators of pain: variation of heart rate, blood pressure, respiratory rate, sweating. To assess the degree of pain when applying two painful procedures documented as common in the usual care of critically ill patients, and one non-painful procedure, using two pain scales: ESCID and BPS. To assess the differences in the employment of the pain scales in patients with medical and surgical pathology.

Interventions

OTHERPain measurement

Pain intensity will be measured using 2 scales based on behaviour items, the Behavioural Pain Scale (BPS) and the ESCID scale (Escala de Conductas Indicadoras de Dolor), by two independent observers , when applying two procedures registered as painful (PD) and common in clinical practice, and a non-painful procedure (PND). The measurement will be performed once per each patient and procedure. The procedures to be studied are the following: * TURNING / POSITIONING (moving side to side or up or down in bed) * ENDOTRACHEAL SUCTIONING (insertion of suction catheter into the endotracheal tube or tracheostomy in order to aspirate secretions) * NON PAINFUL PROCEDURE (Soft friction with gauze cloth on a healthy skin tissue portion, in the outer arm, forearm or anterior tibial area)

Sponsors

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
CollaboratorOTHER
Hospital Universitario Getafe
CollaboratorOTHER
Hospital Universitario 12 de Octubre
CollaboratorOTHER
Hospital Universitario Ramon y Cajal
CollaboratorOTHER
Hospital General Universitario Gregorio Marañon
CollaboratorOTHER
Hospital San Carlos, Madrid
CollaboratorOTHER
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
CollaboratorOTHER
Quirón Madrid University Hospital
CollaboratorOTHER
Hospital de Cruces
CollaboratorOTHER
Hospital de Basurto
CollaboratorOTHER
Hospital Galdakao-Usansolo
CollaboratorOTHER_GOV
Hospital Universitario Fundación Alcorcón
CollaboratorOTHER
Hospital Universitario de Fuenlabrada
CollaboratorOTHER
Puerta de Hierro University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patient must be 18 years of age or older * Patient's primary language spanish where the evaluation is performed * Patient meets IRB/Central EC requirements of the institution/ country where the evaluation is performed * Patient is receiving the study's procedures as part of standard care, excepting the non painful procedure

Exclusion criteria

* Patient's condition is very unstable at the time of measurement of pain * Patient is receiving neuromuscular blocking medications at the time of measurement of pain * Patient´s probable or diagnosed delirium

Design outcomes

Primary

MeasureTime frameDescription
Pain intensity20 minutesPain intensity will be measured through the use of 2 scales based on behaviour items, the Behavioural Pain Scale (BPS) and the ''Scale of Behavioral Indicators of Pain'' (ESCID-Escala de Conductas Indicadoras de Dolor), by two independent observers with blind result among them, when the application of two procedures registered as painful (PD) and common in clinical practice, mobilization and tracheal suctioning, and one non-painful procedure (PND). The measurement will be performed once per each patient and procedure. The measurement of pain will be carried out in 3 stages: 5 minutes before the PD/PND, during PD/PND and 15 minutes after PD/PND.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026